Handling

ABSTRACT

The present invention refers to a flexible single or multiple chamber bag for storing medical products comprising at least one chamber. 
     In particular the invention refers to a flexible single or multiple chamber bag ( 10 ) for storing medical products comprising a hanger flap  11  extending from the top end of said bag, characterized in that said flap  11  contains 
     a) two mirror inverted circular cuttings ( 1 ) and ( 2 ) of an angle of 145° to 180°, wherein one end of each of said cuttings ( 1 ) and ( 2 ) is spaced apart by a connecting cutting ( 3 ) being essentially being straight-lined having a length of 4 times to 10 times the radius of said circular cuttings ( 1,2 ) and
 
b) two mirror inverted circular cuttings ( 4 ) and ( 5 ) of an angle of 180° to 270°, having a radius of 0.3 to 0.7 of the radius of said cutting ( 1 ) and ( 2 ), wherein one end of each of said cuttings ( 4 ) and ( 5 ) is spaced apart by a connecting cutting ( 6 ) having the shape of the letter “U”,
 
c) wherein said cuttings ( 1 ), ( 2 ), ( 4 ), and ( 5 ) are positioned along a common mirror symmetry axis through the centers of said cuttings ( 3 ) and ( 6 ) and the basis of said letter “U” and
 
d), the distance of the center of said cutting ( 3 ) and the basis of said letter “U” corresponds to the 0.5 to 1.5 times the radius of said cuttings ( 1 ) and ( 2 ).

The present invention refers to a flexible single or multiple chamberbag for storing medical products comprising at least one chamber.

In the pharmaceutical industry and especially in the field of perfusionsolutions, impermeable flexible bags are extensively used. Such bags orcontainers are prepared from polymerized materials which have to meet awide variety of requirements. Thus, in particular, gas and vaportightness, transparency, printability and inertness towards thesubstances they contain, are of essential importance as well as thehandling by the nurse administering the medical products to the patient.The substances contained in the containers or bags essentially consistof salts and solutions thereof, carbohydrates, amino acids and lipids.They are usually employed in single or multicompartment bags, theindividual compartments or chambers being filled with one or differentcomponents.

EP 0 295 204 131 describes a container for medical use, in particular acontainer for infusions consisting of an envelope made of a flexible,homogeneous, polymerized material which is divided into threecompartments, separated from each other by leaktight welds of theenvelope material and each of said compartments is provided with anoccluded passage which can be opened deliberately to enable the contentsof the part of the interior space to flow into another one. In use thecontainer may be affixed by an eyebolt having the typical shape of sucheyebolt for hanging blister packs to a peg. A proper hanging of theheavy container requires stiffening of the flap around the eyebolt andcauses handling disadvantages.

EP 1 011 605 132 relates to a flexible plastic container (1) for thespatially separated storage and, optionally, selective sterilization ofthe ingredients of preparations of parenteral or enteral use, consistingof only three compartments. Said document simply uses a circular eyeboltin the area of the top of said bag in use and a second eyebolt locatedwithin the sealed weld separating the upper chamber from the lowerchamber. The use of such second eyebolt is possible due to the use ofthe special connecting means made as breakable valves.

WO 2007/037793 A1 relates to a multiple chamber container for separatelystoring components of a parenteral nutritional formulation. The multiplechamber container may include frangible barriers, preferably peelableseals separating the chambers from each other. The container preferablyfacilitates the selective activation of the peelable seals to permit theadmixing of less than all the separately stored components. Thecontainer may include a hanger flap extending from the top end of thecontainer towards the bottom end of substantially greater distancerelative to the at least one additional chamber than the lateralchambers. At the top end of the container, in particular opposite endwhere the administration port(s) are located, there is provided a hangerportion being a flap having a centrally located hole for hanging thecontainer. The flap defines a border of the upper end of all thechambers. The central portion of the hanger flap extends a substantialdistance towards the bottom end of the container, in particular aboutone-fourth the longitudinal length L of the container. In particular,the flap extends a greater distance towards the bottom end at least atthe central chamber and can also extend a greater distance towards thebottom end at the central chamber and at one of the other chambers. Thisextra extension of the flap with respect to center chamber results insaid chamber having a shorter longitudinal length than the longitudinallength of lateral or side end chambers.

Thus, it is the aim of the present invention to simplify the handling ofa flexible single or multiple chamber bag for storing medical productsand in particular to improve the use thereof by the nurse whenadministering the medical products to the patient.

The above objects of the invention are met in a first embodiment of theinvention by a flexible single or multiple chamber bag 10 for storingmedical products comprising a hanger flap 11 extending from the top endof said bag, which is characterized in that said hanger flap 11 contains

a) two mirror invented circular cuttings 1 and 2 of an angle of 145° to180°, wherein one end of each of said cuttings 1 and 2 is spaced apartby a connecting cutting 3 being essentially being straight-lined havinga length of 4 times to 10 times the radius of said circular cuttings 1,2andb) two mirror invented circular cuttings 4 and 5 of an angle of 180° to270°, having a radius of 0.3 to 0.7 of the radius of said cuttings 1 and2, wherein one end of each of said cuttings 4 and 5 is spaced apart by aconnecting cutting 6 having the shape of the letter “U”,c) wherein said cuttings 1, 2, 4, and 5 are positioned along a commonmirror symmetry axis through the centres of said cuttings 3 and 6 andthe basis of said letter “U” andd), the distance of the center of said cutting 3 and the basis of saidletter “U” corresponds to the 0.5 to 1.5 times the radius of saidcuttings 1 and 2.

Due to the specific structure of the hanger flap of a single or multiplechamber bag, the object of the invention as outlined above is met.

FIG. 1 in detail shows a flexible three chamber bag 10 according to thepresent invention, which is intended for storing medical products. Itgoes without saying that the number of chambers and the specific shapeis illustrative only. The inventive concept of the hanger flap may betransformed to all kinds of single or multiple chamber bags. Themultiple chamber bag according to the present invention in FIG. 1contains three adjacent chambers.

Selected seams or welds within the circumferential weld 7 may bepeelable when applying pressure on the bag 10 independent from thetechnique of the nurse by applying pressure or by rolling the multiplechamber bag 10.

The single or multichamber bag according to the present invention ismade of a flexible polymeric film having a region with a higher meltingpoint designated as its outside and having a region with a lower meltingpoint designated as its sealing inside, which can be sealed together bymeans of conventional welding tools to permanent or peelable seams. Itis to be understood that the inner region is intended to face the storedcomponents and can form both, permanent seams and different peelableseams when subjected to different welding conditions or operations. Itis in particular preferred that the film is made of at least twodifferent polymer layers wherein the inside layer is a sealant layerbeing capable of forming both, permanent seams and peelable seams whensubjected to welding at different temperatures. Polymeric materialsproviding said features are known from in particular the prior art.

The bag 10 according to the present invention comprises a hanger flap 11extending from the top end of said bag next to the upper chamber inparticular within the circumferential weld 7.

FIG. 2 is a detailed view of the hanger flap 11 according to the presentinvention. The hanger flap 11 contains two different cuttings which areseparated to each other and are intended to fulfil different purposes.The upper cutting next to the outer edge of the circumferential weldcontains three different parts 1, 2, 3 having a size and shape for theinsertion of at least four or five fingers of a standard hand of anurse. Two mirror inverted circular cuttings 1 and 2 describe an angleof 145° to 180°, wherein one said cuttings 1 and 2 are spaced apart by aconnecting cutting 3 being essentially straight lined. Preferably, theconnecting cutting 3 has the shape of a palm and connects the outercircular cuttings 1 and 2. The radius of the circular cuttings 1 and 2is adapted to the average size fitting a palm and thus compares to theaverage size of a usual finger of a hand. The distance between thecircular cuttings 1 and 2 compares to the average width of a standardpalm allowing the insertion of at least four or five fingers of astandard hand. Thus, the length of the cutting 3 according to presentinvention preferably is four times to ten times the radius of saidcircular cuttings.

Additional mirror inverted circular cuttings 4 and 5 are locatedsymmetrically to the upper cuttings 1,2,3. Said cuttings 4 and 5 arespaced apart but connected by a connecting cutting 6 having the shape ofthe letter “U” like a nose. The purpose for this specific double eyeboltallows a proper hanging of the bag to an appropriate pole or peg duringthe administration of the content of the bag via a port at the lower endof the bag to the patient. Two mirror inverted circular cuttings 4 and 5each of an angle of 180° to 270° having a smaller radius than saidcuttings 1 and 2 are connected via a connecting cutting 6. The purposeof the connecting cutting 6 with the shape of the letter “U” is to bearthe load of the filled bag. Due to this specific shape no additionalstiffening of the hanger flap is required.

The upper cuttings 1,2 and the lower cuttings 4, 5 are positioned alonga common mirror symmetry axis through the center of said cuttings 3 and6.

The distance of the upper cuttings 1,2,3 to the lower cuttings 4,5,6 isdetermined by the stability of the foils of the bag. In case saiddistance is too small rupture may take place destroying the lowercuttings 4,5,6. On the other hand, in case the distance of the uppercuttings 1,2,3 to the lower cuttings 4,5,6 is too large the overall sizeof the hanger flap becomes too large causing disadvantages during theuse in the hospital. In a preferred embodiment of the present invention,the flexible single or multiple chamber bag 10 contains two, three, fouror more chambers whereby a three or four chamber bag is in particularlypreferred.

As mentioned above, the bag 10 according to the present invention inparticular contains medical products, such as solutions, emulsions,suspensions and/or dispersions suitable for parenteral or enteralnutrition of patients.

In particular, the chamber partially separating an upper chamber and alower chamber contains a fat emulsion. Accordingly, the upper chambercontains a carbohydrate solution and the lower chamber contains an aminoacid solution. The features of the bag as described above ensure a rapidmixing and complete emulsification of all contents of the container forthe administration of the content to the patient via a port at the lowerend of the bag.

1. A flexible single or multiple chamber bag (10) for storing medical products comprising a hanger flap 11 extending from the top end of said bag, characterized in that said flap 11 contains a) two mirror inverted circular cuttings (1) and (2) of an angle of 145° to 180°, wherein one end of each of said cuttings (1) and (2) is spaced apart by a connecting cutting (3) being essentially being straight-lined having a length of 4 times to 10 times the radius of said circular cuttings (1, 2) and b) two mirror inverted circular cuttings (4) and (5) of an angle of 180° to 270°, having a radius of 0.3 to 0.7 of the radius of said cutting (1) and (2), wherein one end of each of said cuttings (4) and (5) is spaced apart by a connecting cutting (6) having the shape of the letter “U”, c) wherein said cuttings (1), (2), (4), and (5) are positioned along a common mirror symmetry axis through the centers of said cuttings (3) and (6)and the basis of said letter “U” and d), the distance of the center of said cutting (3) and the basis of said letter “U” corresponds to the 0.5 to 1.5 times the radius of said cuttings (1) and (2).
 2. The flexible bag (10) according to claim 1, characterized in that the cuttings (1), (2), (4) and (5) essentially terminate to the direction of the bottom of the bag when in use.
 3. The flexible bag according to claim 1, characterized in that the overall length of cuttings (1), (2), and (3) is sufficient holding four fingers of a standard hand. 